CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced that Phase
2b trial data comparing first-line treatment with aldoxorubicin, its
lead product candidate, versus doxorubicin in patients with advanced
soft tissue sarcomas (STS) has been selected for oral presentation at
the 2014 American Society for Clinical Oncology (ASCO) Annual Meeting,
which is taking place May 30 – June 3 in Chicago.
Oral presentation details:
Title: “Randomized phase 2b trial comparing first-line treatment
with aldoxorubicin versus doxorubicin in patients with advanced soft
tissue sarcomas”
Presenter: Sant Chawla, M.D., F.R.A.C.P., Sarcoma Oncology Center
Abstract #: 10502
Date and Time: Sunday, June 1, 2014, 8:24 am – 8:36 am CDT
Session ID: Oral abstract session: Sarcoma
Embargo: ASCO’s embargo for this
abstract will lift on Wednesday, May 14, at 5 pm EDT
Aldoxorubicin is currently being studied in a pivotal, global Phase 3
clinical trial evaluating the efficacy and safety of aldoxorubicin as a
second-line treatment for patients with STS under a Special Protocol
Assessment with the FDA. CytRx is also conducting two Phase 2 clinical
trials evaluating aldoxorubicin in patients with late-stage glioblastoma
(GBM) and HIV-related Kaposi’s sarcoma.
CytRx is hosting a Research and Development Day on Friday, May 2, from
8:30 am – 11:30 am EDT at the Harvard Club in New York City where these
and other studies will be discussed.
The event, which will be open to analysts and institutional investors,
will include presentations by, and a panel discussion with, key opinion
leaders in oncology and sarcoma, including the principal investigator
for the Company’s pivotal, global Phase 3 trial of aldoxorubicin in
patients with soft tissue sarcoma. Breakfast will be served. CytRx
invites the public and the media to join the event via the webcast.
Please RSVP to maeve@argotpartners.com.
A webcast of the presentation can be accessed at the following link: http://wsw.com/webcast/cc/cytr/register.aspx?conf=cc&page=cytr&url=http%3A//wsw.com/webcast/cc/cytr/
A replay of the webcast will also be archived on the Investor Relations
section of the CytRx website following the event.
About Aldoxorubicin
The widely used chemotherapeutic agent doxorubicin is delivered
systemically and is highly toxic, which limits its dose to a level below
its maximum therapeutic benefit. Doxorubicin also is associated with
many side effects, especially the potential for damage to heart muscle
at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines
doxorubicin with a novel single-molecule linker that binds directly and
specifically to circulating albumin, the most plentiful protein in the
bloodstream. Protein-hungry tumors concentrate albumin, thus increasing
the delivery of the linker molecule with the attached doxorubicin to
tumor sites. In the acidic environment of the tumor, but not the neutral
environment of healthy tissues, doxorubicin is released. This allows for
greater doses (3 ½ to 4 times) of doxorubicin to be administered while
reducing its toxic side effects. In studies thus far there has been no
evidence of clinically significant effects of aldoxorubicin on heart
muscle, even at cumulative doses of drug well in excess of 2 g/m2.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development
company specializing in oncology. CytRx currently is focused on the
clinical development of aldoxorubicin (formerly known as INNO-206), its
improved version of the widely used chemotherapeutic agent doxorubicin.
CytRx has completed a global Phase 2b clinical trial with aldoxorubicin
as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical
trial primarily in the same indication, a Phase 1b study of
aldoxorubicin in combination with doxorubicin in patients with advanced
solid tumors and a Phase 1b pharmacokinetics clinical trial in patients
with metastatic solid tumors. CytRx has initiated under a special
protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as
a therapy for patients with soft tissue sarcomas whose tumors have
progressed following treatment with chemotherapy, and recently announced
that it has received approval from the FDA to continue dosing patients
with aldoxorubicin until disease progression in that clinical trial.
CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in
patients with late-stage glioblastoma (brain cancer), and a Phase 2
clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand
its pipeline of oncology candidates based on a linker platform
technology that can be utilized with multiple chemotherapeutic agents
and may allow for greater concentration of drug at tumor sites. CytRx
also has rights to two additional drug candidates, tamibarotene and
bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE
Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia
(B-CLL), and plans to seek a partner for further development of
bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended. Such statements involve risks and uncertainties that could
cause actual events or results to differ materially from the events or
results described in the forward-looking statements, including risks
relating to the outcome, timing and results of CytRx's clinical trials,
the risk that any future human testing of aldoxorubicin, might not
produce results similar to those seen in past human or animal testing,
risks related to CytRx's ability to manufacture its drug candidates in a
timely fashion, cost-effectively or in commercial quantities in
compliance with stringent regulatory requirements, risks related to
CytRx's need for additional capital or strategic partnerships to fund
its ongoing working capital needs and development efforts, including the
Phase 3 clinical development of aldoxorubicin, and the risks and
uncertainties described in the most recent annual and quarterly reports
filed by CytRx with the Securities and Exchange Commission and current
reports filed since the date of CytRx's most recent annual report. All
forward-looking statements are based upon information available to CytRx
on the date the statements are first published. CytRx undertakes no
obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Copyright Business Wire 2014